Comparison of the Safety of Flublok® Versus Licensed IIV in Healthy, Medically Stable Adults ≥ 50 Years of Age

Phase 3

Completed

• Conditions: Influenza
• Interventions: Biological: Afluria; Biological: Flublok

• Registration Number: NCT01825200
• Lead Sponsor: Protein Sciences Corporation

Brief Summary

The hypothesis for this trial is that the incidence of a pre-defined composite of common systemic hypersensitivity adverse events for Flublok recipients is non-inferior to that reported for licensed IIV recipients. Another hypothesis is that the safety and reactogenicity of Flublok is clinically acceptable, i.e. consistent with the overall safety profiles previously observed with Flublok and with the licensed comparator.

Detailed Description

The Advisory Committee on Immunization Practices (ACIP) recommends that all people aged 6 months and older be immunized to prevent influenza. Currently the only approved influenza vaccine across the entire age group is inactivated influenza vaccine (IIV). A Biologics Licensing Application (BLA) for Flublok was approved by the FDA for influenza immunization of adults 18-49 years of age. Additional safety and, ultimately efficacy, data is needed to support use in adults ≥50 years of age, an important age group as adults ≥65 years of age are among those at increased risk of influenza complications.

Study Timeline

• Study Start: 2013-03
• Study First Submitted: 2013-03-11
• Study First Submitted QC: 2013-04-02
• Study First Posted: 2013-04-05
• Primary Completion: 2013-05
• Study Completion: 2013-05
• Results First Submitted: 2014-12-19
• Status Verified: 2015-01
• Results First Submitted QC: 2015-01-29
• Last Update Submitted: 2015-01-29
• Results First Posted: 2015-02-18
• Last Update Posted: 2015-02-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2640

Inclusion Criteria

1. Ambulatory adults aged 50 years and older
2. Medically stable, as determined by medical history and targeted physical examination based on medical history, if appropriate
3. Able to understand and comply with planned study procedures
4. Provides written informed consent prior to initiation of any study procedure.

Exclusion Criteria

1. Known contraindication to either study vaccine (see product package inserts)
2. Receipt of any other influenza or other vaccine within 30 days prior to enrollment in this study.
3. Receipt of any new medication within 30 days prior to enrollment in this study
4. Plans to participate in any investigation involving an investigational product during this study.
5. Pre-existence of atopic dermatitis or any other cutaneous disorder that could complicate the evaluation of potential primary endpoints.
6. Any clinical or social circumstance that in the opinion of the investigator could interfere with compliance with study procedures or interfere with the interpretation of clinical data.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Afluria	Afluria	Afluria, containing 3x15µg (45µg total), of trivalent, inactivated influenza vaccine (licensed IIV) containing influenza antigen derived from A/H1N1 and A/H3N2 and influenza B viruses in a total volume of 0.5 mL
Flublok	Flublok	Flublok containing 3x45µg (135µg total) of recombinant hemagglutinin (rHA) derived from influenza A/H1N1 and A/H3N2 and influenza B viruses in a total volume of 0.5 mL

Primary Outcome Measures

Name	Time	Method
Number of Participants With Common Hypersensitivity Reactions as Measure of Safety	30 Days	Number of participants who experience a pre-defined common systemic hypersensitivity adverse event, including rash, urticaria, swelling or edema through Day 30 post-vaccine administration.

Secondary Outcome Measures

Name	Time	Method
Subjects With at Least One Unsolicited Adverse Event in the 30 Days Following Vaccine Administration	30 Days	Subjects with at least one serious adverse event and subjects with at least one medically-attended unsolicited adverse event occurring during the 30 days following vaccine administration
Number of Participants With Local and Systemic Events Reported as a Measure of Safety	7 Days	Number of solicited local and systemic events of reactogenicity reported with the help of a memory aid during the seven days following vaccine administration.
Subjects With at Least One Hypersensitivity Event Reported on Day 0 and Days 0-7 Following Vaccine Administration as a Measure of Safety	7 Days	Subjects with at least one pre-defined common systemic hypersensitivity adverse event, including rash, urticaria, swelling or non-dependent edema on Day 0 and for Days 0 to 7 following vaccine administration

Trial Locations

Locations (11)

Genova Clinical Research; 🇺🇸 Tucson, Arizona, United States

Clinical Research of South Florida; 🇺🇸 Coral Gables, Florida, United States

Heartland Research Associates, LLC; 🇺🇸 Wichita, Kansas, United States

Meridian Clinical Research; 🇺🇸 Omaha, Nebraska, United States

Benchmark Research; 🇺🇸 San Angelo, Texas, United States

Regional Clinical Research; 🇺🇸 Binghamton, New York, United States

Clinical Research Center of Nevada, LLC; 🇺🇸 Las Vegas, Nevada, United States

Maine Research Associates, LLC; 🇺🇸 Auburn, Maine, United States

Wake Research; 🇺🇸 Raleigh, North Carolina, United States

Research Across America; 🇺🇸 Dallas, Texas, United States

Rapid Medical Research, Inc.; 🇺🇸 Cleveland, Ohio, United States